ADIponectin and Asymmetric Dimethylarginine (ADMA) Level... | NCT01204580

ID	Type	Description	Link
U1111-1116-8173	Other Identifier	UTN

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Sep 16, 2010

First Submission Date that Met QC Criteria

Sep 16, 2010

First Posted Date

Sep 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2012

Last Update Posted Date

Apr 3, 2012Estimated

Description Module

Brief Summary

Primary Objective:

To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA) in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M

Secondary Objectives:

To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in type 2 diabetes patients after 8 weeks of therapy
To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M
To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))
To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M
To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M
To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M
To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level

Detailed Description

The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of treatment period.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amaryl-M (Glimepiride + Metformin)	Experimental	Glimepiride 1 mg and metformin 250 mg are the active ingredients of Amaryl-M 1/250 mg film coated tablets. Starting dosage is 1 tablet per day, then dosage titration will be based on the result of patient FBG test.	Drug: GLIMEPIRIDE + METFORMIN

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GLIMEPIRIDE + METFORMIN	Drug	Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day	Amaryl-M (Glimepiride + Metformin)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes		from baseline to end of Clinical Trial (12 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Change in adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels		at week 8
Pulse Wave Velocity (PWV) change		at week 8 and week 12
Change in Fasting Blood Glucose (FBG)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Type 2 diabetes mellitus patients
Patients with HbA1c >or= 7.0% and < 10.0%
Patients not currently treated with any oral antidiabetic drugs (OADs)

Exclusion criteria:

Participation in other investigational Clinical Trial
Current temporary insulin treatment: gestational diabetes, pancreas cancer, surgery etc.
Women who are pregnant and lactating
Type 1 diabetes mellitus patients
Treatment with antihypertensive Angiotensin-Converting Enzyme (ACE)-Inhibitors and/or Angiotensin II Receptor Blocker (ARB) or has just stopped treatment for less than two months
Treatment with lipid lowering agent statins or has just stopped treatment for less than two months
Known hypersensitive to any of the excipients of Amaryl-M, sulphonylureas, sulfonamides or biguanide
Patients with active smoking or history of smoking cessation less than 2 months
Patients with history of severe hepatic dysfunction
Patients with serum creatinine >or= 1.5 mg/dL (male) and >or= 1.4 mg/dL (female)
Patients with congestive heart failure requiring pharmacologic treatment
Treatment with antifungal agent especially Miconazole

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
C057619	glimepiride
D008687	Metformin

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals